Modular analyte measurement system with extendable strip port

ABSTRACT

A modular analyte measurement system having a removable strip port module. In one embodiment, the analyte measurement system includes: an analyte meter; a removable strip port module; and a connector linking the removable strip port module to the analyte meter. The analyte meter includes: a meter housing; a receptacle formed in the meter housing; a processing circuit disposed within the housing; and an input interface within the receptacle and electrically coupled to the processing circuit. The removable strip port module includes: a module housing sized to at least partially fit within the receptacle of the analyte meter; an analyte test strip port disposed within the module housing to receive an analyte test strip via an aperture formed in the module housing; and an output interface coupled to the analyte test strip port. The connector links the output interface with the input interface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/248,855, filed on Apr. 9, 2014, which is a continuation of U.S.patent application Ser. No. 13/297,091, filed on Nov. 15, 2011, now U.S.Pat. No. 8,702,928, which claims the benefit of U.S. ProvisionalApplication No. 61/416,239, filed on Nov. 22, 2010, the disclosures ofwhich are herein incorporated by reference in their entirety.

RELEVANT APPLICATIONS

This application is related to U.S. patent application Ser. No.12/175,279, filed on Jul. 17, 2008. This application is also related toU.S. patent application Ser. No. 12/495,662, filed on Jun. 30, 2009, andSer. No. 12/624,231, filed on Nov. 23, 2009, both of which claimpriority to U.S. patent application Ser. No. 12/175,279. Thisapplication is also related to U.S. Provisional Patent Application No.61/406,860, filed Oct. 26, 2010. The disclosures of the above-mentionedapplications are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates to analyte measurement systems. Morespecifically, the present invention relates to analyte measurementsystems having a removable strip port module.

2. Background

One of the tools used in diabetes management is an analyte measurementdevice (or analyte meter). An analyte measurement device is typicallyused to measure the blood glucose level of a person based on a sample ofblood. In practice, a user inserts an analyte test strip into a teststrip port of the measurement device. The user then lances her finger toobtain a small sample of blood. The blood sample is then placed onto theanalyte test strip, and the measurement device analyzes the bloodsample. The measurement device then typically displays a blood glucoselevel from the analysis.

In order to ensure an accurate measurement is being generated, it isnecessary to keep the measurement device free from contamination. Thereare instances where the strip port may become contaminated with blood orother fluids (e.g., calibration fluid). When this occurs, theperformance of the measurement device suffers and the user is no longerassured an accurate result. As such, the user may need to purchase a newmeasurement device.

Dedicated hospital meters, for example, have high occurrence rates ofcontamination due to factors such as heavy use, need for calibration,disinfection protocols, and other environmental factors. Contaminationof a hospital meter, and the subsequent need to replace the hospitalmeter, is costly. Further, the inventors have found that a substantialnumber of hospital meters are returned to the manufacturer simplybecause the strip port has been contaminated, while most of the otherparts of the meter remain entirely functional.

Additionally, hospital meters that are used in isolation facilities aresubject to strict disinfection protocols to ensure that the meter isfree from bacteria or harmful microorganisms. Such protocols includeharsh cleaning agents, as well as specialized carrying cases orisolation bags to prevent the meter from contacting a patient.

Another disadvantage of typical hospital meters is that they are manytimes too large and cumbersome for neonatal screening. Typical hospitalmeters are difficult to maneuver within the restricted confines of aneonate bed. While portable hand-held blood analyte meters have beenavailable for many years, most portable hand-held meters are intendedfor self-monitoring of individuals, and lack the functionality ofprofessional dedicated hospital meters. Dedicated hospital meters, forexample, include functionality such as (but not limited to): multiplepatient use; tracking of patient and/or operated identification; barcodescanning of patient, operator, or test strips; database management; datatransfer; system-wide connectivity; etc.

BRIEF SUMMARY

Presented herein is a modular analyte measurement system having aremovable strip port module. Embodiments of the present invention relateto modular components of the analyte measurement system. In oneembodiment, for example, there is provided an analyte measurementsystem, comprising: an analyte meter; a removable strip port module; anda connector linking the removable strip port module to the analytemeter. The analyte meter includes: a meter housing; a receptacle formedin the meter housing; a processing circuit disposed within the housing;and an input interface within the receptacle and electrically coupled tothe processing circuit. The removable strip port module includes: amodule housing sized to at least partially fit within the receptacle ofthe analyte meter; an analyte test strip port disposed within the modulehousing to receive an analyte test strip via an aperture formed in themodule housing; and an output interface coupled to the analyte teststrip port. The connector links the output interface with the inputinterface.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated herein, form part ofthe specification. Together with this written description, the drawingsfurther serve to explain the principles of, and to enable a personskilled in the relevant art(s), to make and use the present invention.

FIG. 1 illustrates a plan view of an analyte measurement system,including an analyte meter and a removable strip port module.

FIG. 2 illustrates a plan view of an analyte measurement system,including an analyte meter and a removable strip port module, inaccordance with an alternative embodiment presented herein.

FIG. 3 illustrates a side view of an alternative connector form.

FIG. 4 illustrates the removable strip port module of FIG. 3, providedwithin a section of an analyte meter.

FIG. 5 is a perspective view of an analyte measurement system, inaccordance with one embodiment presented herein.

FIG. 6 is a perspective view of a removable strip port module, inaccordance with one embodiment presented herein.

FIG. 7 is a rear perspective view of the removable strip port module ofFIG. 6.

FIG. 8 is an exploded view of a removable strip port module, inaccordance with one embodiment presented herein.

FIG. 9 illustrates a plan view of an analyte measurement system, inaccordance with one embodiment presented herein.

FIG. 10 illustrates a side view of the analyte measurement system ofFIG. 9.

FIG. 11 illustrates a plan view of an analyte measurement system, inaccordance with one embodiment presented herein.

FIG. 12 illustrates a perspective view of the analyte measurement systemof FIG. 11.

DETAILED DESCRIPTION OF THE INVENTION

Before the embodiments of the present disclosure are described, it is tobe understood that this invention is not limited to particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the embodiments of the invention will belimited only by the appended claims.

Embodiments presented herein relate to systems and methods where arelatively smaller sub-assembly (e.g., removable strip port module)serves as an extension of a dedicated hospital analyte meter. Thesub-assembly is designed to facilitate “bedside” testing of a patient.For example, in one embodiment, a removable strip port module isconnected to an analyte meter through a physical connection, such as anextension cable. In another embodiment, the removable strip port moduleis connected to the analyte meter through a wireless interface. Duringtesting, the removable strip port module can be separated from the meterand used to test the patient. As such, the meter does not need to becarried to the patient.

In one embodiment, a removable strip port module is a mechanical andelectrical sub-assembly that “plugs” into the Analog Front End (AFE) ofan analyte meter via a connector. The connector may be a cable, cord, orother extension piece that routes data and/or other electrical signalsfrom the removable strip port module to the meter. The removable stripport module and/or meter may include mechanical engagement features tohouse the module and/or assist in the connection between the module andthe meter.

In one embodiment, the removable strip port module includes a test stripreceptacle mounted on a printed circuit board assembly (PCBA)daughter-card. The test strip receptacle and PCBA daughter-card are thenenclosed in a module housing with a slit or aperture at one end, for thestrip port opening, and an opening for a cable exiting on the other end.The cable is attached to the PCBA daughter-card, for example, throughsoldering or heat-bar. The opposite end of the cable may have aconnector to interface with a mating connector within the meter. Thecable may be a fixed length or retractable/extendable. The PCBAdaughter-card may also have active components, such as op-amps, andsupporting passive components in order to enhance the signal strengthand assure adequate electrical signal levels reach the meter AFE.Alternative embodiments may include a rigid flex cable design; apress-fit engagement between the module and the meter; a through-hole inthe meter for cable access; surface mounted connectors; a ribbon cable;mechanical potting; and one-time or multiple use connection option.

The removable strip module may also transfer signals from the strip portconnector to the meter through a non-physical connection, such as awireless connection. In such embodiment, the removable strip port modulePCBA would also include a power supply and active components to supporta wireless data transfer module. The meter would also include a wirelesstransceiver to support data transfer. The wireless connection may be astandard type, such as IEEE 802.11, or a proprietary wireless busprotocol. With a wireless removable strip port module, there would be noneed for a cable, and the module would thus “detach” from the meter whenneeded for testing.

Prior to detaching the module from the meter, the meter can beconfigured to charge a power supply on the removable module (e.g., arechargeable battery or capacitor). The module may also be directlycharged through a separate power supply.

As such, in one embodiment, there is provide an analyte measurementsystem including a dedicated hospital meter and one or more removablestrip port modules in wireless communication with the meter. Each of theremovable strip port modules can be kept “bedside” with a patient, andtransmit test data back to the meter when appropriate. As such, eachremovable strip port module can be maintained in a sterile, isolatedfacility, with each patient, while a single dedicated hospital meterreceives and processes that data from each removable strip port module.Further, such system removes the need for the healthcare provider todisinfect the dedicated hospital meter when testing across patients; apractice that many healthcare providers complain about. Further, in suchembodiment, each removable strip port module may transmit data under aunique RFID code. The dedicated hospital meter then includes decodingcircuitry to identify from where the received data is being transmitted.

In certain embodiments, the removable strip port modules describedherein are configured for real-time data/signal transfer to a meter viaa connector. In other embodiments, the removable strip port modulesdescribed herein include a processor and memory unit for signal-to-dataconversion and temporary storage of the analyte data. The removablestrip port module may then be “plugged” into the meter for downloadingof the analyte data.

The following detailed description of the figures refers to theaccompanying drawings that illustrate an exemplary embodiment of ananalyte measurement system. Other embodiments are possible.Modifications may be made to the embodiment illustrated withoutdeparting from the spirit and scope of the present invention. Therefore,the following detailed description is not meant to be limiting.

FIG. 1 illustrates a plan view of an analyte measurement system 100,including an analyte meter 105 and a removable strip port module 110. Asshown, removable strip port module 110 includes a test strip receptacle115 for receiving an analyte test strip 120. While test strip receptacle115 is provided on the opposite side of the output interface of module110, test strip receptacle 115 may be provided on any side of module110. Removable strip port module 110 also includes an output interfacethat is electrically coupled to an input interface (e.g., AFE) ofanalyte meter 110 via a connector 130, such as a cable, cord,serial/parallel bus, or other equivalent connector means. Internalcontacts or traces 140 transmit electrical signals and/or data betweenconnector 130 and a processing unit 150 within a meter housing 160 ofanalyte meter 105.

Further, removable strip port module 110 may be sized and shaped to atleast partially fit within a receptacle formed in housing 160 of analytemeter 105. Module 110 may further include one or more retention tabs162, which are configured to align and/or engage module 110 to receivingtabs 164 on meter housing 160. The interface between module 110 andmeter housing 160 may be configured to be substantially impervious tocontaminants. In another embodiment, module 110 may be coupled to meter105 via a press-fit or snap-fit engagement.

Analyte meter 105 may further include a user interface 170, such as atouch-screen monitor to display test results and receive input from auser.

In one embodiment, connector 130 and internal traces 140 may include avariety of data transfer channels. For example, connector 130 andinternal traces 140 may include three channels plus a ground channel forone type of removable strip port module, three channels plus a groundchannel for a second type of removable strip port module, a channel toidentify the removable strip port module, and a channel to identify whattype of test strip is being used (e.g., glucose, ketone, etc.). As such,connector 130 and internal traces 140 increase the functionality ofanalyte meter 105 by allowing it to be used with multiple differentremovable strip port modules.

FIG. 2 illustrates a plan view of an analyte measurement system 200,including an analyte meter 205 and removable strip port module 210, inaccordance with an alternative embodiment presented herein. As shown,removable strip port module 210 includes a test strip receptacle 215 forreceiving an analyte test strip 220. Removable strip port module 210also includes an output interface that is electrically coupled to aninput interface of analyte meter 205 via a connector 230; such as acable, cord, serial/parallel bus, or other equivalent connector means.Connector 230 may be a fixed length cable, or a retractable cord.Connector 230 may also include a winding mechanism to provide variablelength extension. One such winding mechanism is described in U.S. Pat.No. 6,733,328, which is herein incorporated by reference in itsentirety.

Test strip receptacle 215 is mounted on a PCBA daughter-card 216, forelectrical communication between test strip receptacle 215 and connector230. As shown, test strip receptacle 215 is provided on the oppositeside of the output interface of module 210. However, test stripreceptacle 215 may be provided on any side of module 210.

In the embodiment shown, removable strip port module 110 is notconfigured to fit within a receptacle formed in the meter housing 260.Instead, module 110 is provided as an independent unit that electricallycouples to meter 205 only through connector 230.

Analyte meter 205 may include a user interface, such as a display 270and hard/soft buttons 272.

FIG. 3 illustrates a side view of an alternative connector form betweenremovable strip port module 310 and an input interface 340 in an analytemeter. FIG. 4 illustrates removable strip port module 310 within asection of meter housing 360. In the embodiment shown, removable stripport module 310 is electrically coupled to input interface 340 within ananalyte meter via connector 330. In such embodiment, connector 330 is asoldered wire electrically coupled to leads in module 310. A heat sink317 may be provided for thermal control of connector 330. Electricalcurrent flows from module 310 to interface 340, and then to PCBA 390 viacontacts 380.

FIG. 4 illustrates the removable strip port module 310 installed withinmeter housing 360. A gasket 365 aligns and maintains removable stripport module 310 within meter housing 360. A second gasket 366, such asan o-ring, may also be employed to further align and maintain removablestrip port module 310 in place, as well as keep contaminants fromentering meter housing 360. As shown in FIG. 4, connector 330 may belooped during installation and tucked within meter housing 360.Connector 330 is provided with additional length to provide flexibilityand functionality to the system. In the event that a user wishes toperform an analyte test at a distance from the meter, removable stripport module 310 may be withdrawn from meter housing 360 and an analytetest may be performed while the module 310 and meter remain connectedthrough connector 330.

FIG. 5 is a perspective view of an analyte measurement system 500, inaccordance with one embodiment presented herein. System 500 includes aremovable strip port module 510 and an analyte meter 505. FIG. 5illustrates system 500 prior to insertion of removable strip port module510 into analyte meter 505.

Analyte meter 505 may be similar to analyte meters known in the art. Forexample, analyte meter 505 may include similar structures, functions,and components as the analyte meters described in U.S. Pat. No.7,077,328, which is incorporated herein by reference in its entirety. Asshown, analyte meter 505 includes a display panel 570 for displayinginstructions and/or results from an analyte measurement, and a userinterface 572 for inputting commands to the analyte meter. Analyte meter505 also includes internal processing units (not shown) for the analysisof a blood sample. As such, analyte meter 505 includes means foranalyzing an electrical signal received from removable strip port module510. Analyte meter 505, however, has been modified to lack a fullyintegrated analyte test strip port. Instead, analyte meter 505 includesan input interface (e.g., AFE) with a wireless data transceiver toreceive data from removable strip port module 510.

The transmission of data between removable strip port module 510 and theAFE of meter 505 may be a wireless communication, including, but notlimited to, radio frequency (RF) communication (e.g., Radio-FrequencyIdentification (RFID), Zigbee communication protocols, WiFi, infrared,wireless Universal Serial Bus (USB), Ultra Wide Band (UWB), Bluetooth®communication protocols, and cellular communication, such as codedivision multiple access (CDMA) or Global System for Mobilecommunications (GSM).

As shown in FIG. 5, analyte meter 505 includes a receptacle 505 thatprovides an opening in the analyte meter housing 560. Removable stripport module 510 is designed to fit within receptacle 561. Guide features563 are provided in the meter housing 560 to aide in the insertion andalignment of removable strip port module 510 within receptacle 561.Analyte meter 505 also includes a coupling feature 564 (e.g., a screwhole), which aligns with module 510 for permanent or temporaryattachment. Alternative attachment means may also be employed toremovably (or semi-permanently) attach removable strip port module 510to analyte meter 505.

In one embodiment, for example, the meter housing 560 and internalcomponents are formed of medical grade PC/ABS plastic blend, and mayinclude an anti-microbial plastic such as BAYER BAYBLEND AM120FR. In oneembodiment, meter housing 560 is formed of two or more separatecomponents, which are screwed together using M3 stainless steel screws.Such screws may have heads that differentiate them from the strip portretaining screws. For example, such screws may have Torx heads. Internalscrews may be M2.5 zinc-plated, pan head Philips screws.

FIG. 6 is a perspective view of removable strip port module 510, inaccordance with one embodiment presented herein. FIG. 7 is a rearperspective view of removable strip port module 510. FIG. 8 is anexploded view of removable strip port module 510, in accordance with oneembodiment presented herein.

As shown in FIGS. 6-8, removable strip port module 510 includes a modulehousing 511 with a cap 512. An analyte test strip port 515 is disposedwithin an open end of module housing 511, which is then enclosed (orcovered) by cap 512. In one embodiment, analyte test strip port 515 isan electro-chemical strip port. In an alternative embodiment, analytetest strip port 515 is an optical strip port. As shown in FIG. 8,analyte test strip port 515 is coupled to a PCBA 516, and electricalleads of analyte test strip port 515 are electrically coupled to awireless transceiver 530 on PCBA 516. In one embodiment, module 510 mayfurther include a processor (not shown) and/or power source (not shown)mounted on PCBA 516. The power source may be an individual power source,or a rechargeable power source (e.g., a capacitor) that is charged via aconnection to meter 505 when module 510 is plugged into the meter.

In one embodiment, module housing 511 is formed of a plastic mold, andmore preferably an anti-microbial plastic mold. In alternativeembodiments, module housing 511 may be formed of other suitablematerials such as plastics, rubbers, polymers, or other inert materials.In one embodiment, for example, module housing 511 and internalcomponents are formed of medical grade PC/ABS plastic blend, and mayinclude an anti-microbial plastic such as BAYER BAYBLEND AM120FR. In theembodiment shown in FIG. 8, module housing 511 includes internalalignment features, such as internal alignment baffles 598 and internalalignment grooves 599, to properly align analyte test strip port 515 andPCBA 516 within module housing 511. Such internal alignment features,and structures equivalent thereto, serve as means for aligning ananalyte test strip port within the module housing. A screw hole 597 maybe provided in module housing 511 to attach removable strip port module510 to an analyte meter. A screw for use in screw hole 597 may be astainless steel, pan head Philips, thread-forming screw.

Module housing 511 also includes external alignment features or guides562 and beveled surfaces to further support the proper insertion andalignment of removable strip port module 510 within an analyte meter.Such external alignment features, and structures equivalent thereto,serve as means for aligning a removable strip port module within ananalyte meter.

Cap 512 serves to fully encase analyte test strip port 515 within modulehousing 511. In one embodiment, cap 512 is permanently attached tomodule housing 511 with a hermetic seal 513. In an alternativeembodiment, cap 512 may be removably attached to module housing 511. Inanother alternative embodiment, a gasket means (e.g., a rubber o-ring,fabric, etc.) may be used to seal the gap between cap 512 and modulehousing 511. In the embodiment shown, cap 512 also includes an optionaltab extension 521 to facilitate in the insertion and removal ofremovable strip port module 510 from an analyte meter.

Cap 512 further includes an aperture 514, which provides access toanalyte test strip port 515. In operation, an analyte test strip isinserted through aperture 514 and into analyte test strip port 515. Inone embodiment, aperture 514 provides sufficient clearance to accept awide variety of different analyte test strips form factors. In analternative embodiment, aperture 514 may be customized to receive aspecific analyte test strip form factor. Customizing the aperture sizeor shape to a specific analyte test strip form factor can prevent theuse of non-matching or incompatible analyte test strips with analytetest strip port 515. Aperture 514 may also be formed with a one-wayvalve or port protector to swipe across the surface of an analyte teststrip when the analyte test strip is passed through aperture 514. Suchan embodiment may be used to protect analyte test strip port 515 fromunwanted contaminants. In alternative embodiments, aperture 514 mayincorporate one or more port protectors, such as disclosed in U.S.Patent Application Publication No. 2009/0270696, which is incorporatedby reference herein in its entirety.

In the event that unwanted fluids and contaminants enter throughaperture 514 and comprise the function of analyte test strip port 515,removable strip port module 510 can be removed and replaced with a newremovable strip port module. The replacement of removable strip portmodule 510 can be done without discarding or replacing any of thefunctioning components of analyte meter 505. As such, auser/manufacturer can save money by only replacing the components of thesystem 500 that have actually been comprised. Further, the use of module510 simplifies disinfecting procedures because a healthcare providerneed only clean the module 510, and not the entire meter 505.

FIG. 9 illustrates a plan view of an analyte measurement system 900, inaccordance with one embodiment presented herein. FIG. 10 illustrates aside view of the analyte measurement system of FIG. 9. System 900 issimilar to system 500, except that the wireless capability of theremovable strip port module 510 are removed. In system 900, the linkbetween the output interface of module 510 and the input interface ofmeter 505 is provided by a physical wire or cable connection 930.Connection 930 may be modified and customized to be as long as necessaryfor the applicable use. As such, module 510 may be separated from meter505, and used for bedside testing and/or incubator setting; e.g., in aneonatal application. As used herein, the term “separated” needs torequire a complete disconnection. For example, the module may beseparated from the meter, while still electrically coupled/linked via aconnector. In essence, the module is “separated” from the meter suchthat the module may be drawn to the patient without the need of bringingthe meter to the patient.

FIG. 11 illustrates an ornamental plan view of an analyte measurementsystem having a removable strip port module at least partially insertedwithin a receptacle of the meter housing.

FIG. 12 illustrates an ornamental perspective view of an analytemeasurement system having a removable strip port module at leastpartially inserted within a receptacle of the meter housing.

Certain embodiments presented herein relate to electrical interfaces inmeasurement systems. Measurement systems often have electricalinterfaces that allow them to electrically connect with another systemor apparatus and perform an analysis of an analyte. A system thatmeasures blood glucose levels, for example, includes electricalinterfaces that allow the system to measure the blood glucose level froma small blood sample.

Embodiments presented herein also relate to systems and methods that canimprove the mean time before failure (MTBF) in measurement systems. Byimproving the MTBF, a user is provided with a system that lasts longerand has more accurate performance over time.

Embodiments presented herein also relate to strip connectors or stripports that can be cleaned and/or replaced. The ability to clean orreplace a strip port can prevent the system from experiencing problemsoften associated with port contamination. Blood and other contaminants,for example, can often contaminate a port and make the system unusableor result in inaccurate analysis. A port that can be cleaned or replacedwithout affecting the operation of the system thus increases the MTBF.

Embodiments presented herein provide further advantages such as: theability to upgrade strip port modules as new test strip technologiesevolve; the ability to clean or sterilize a strip port module; and theability to allow users to replace strip port modules without returningthe entire measurement system to the manufacture.

Certain embodiments relate to in vivo (e.g., continuous monitoring)systems. A continuous monitoring system typically includes a sensor thatis worn or placed below the skin, a transmitter that collects glucoseinformation from the sensor, and a receiver that collects theinformation from the transmitter. The sensor can collect glucose levelinformation continuously, periodically, or at other intervals.Advantageously, a user is relieved from having to repeatedly lance hisor her body to collect a blood sample once the sensor is inserted,although the sensor (e.g., an electrochemical sensor that is insertedinto a body) can be replaced. U.S. Pat. No. 6,175,752, which is herebyincorporated by reference in its entirety, discloses additional examplesof a continuous monitoring system.

Embodiments of the invention further extend to kits. Examples of a kitinclude a measurement system with one or more removable strip portmodules. In some kits, different removable strip port modules areprovided for different types of strips. This allows the measurementsystem to be used with different strip form factors. The kits may alsoinclude a plurality of test strips. In certain examples, the measurementsystem may be configured for use with disposable test strips as well aswith test strips that are configured for continuous monitoring systems.Thus, the measurement system may include a receiver to receiveinformation from a transmitter that collects glucose information from aninserted sensor.

Analyte Test Strips

Analyte test strips for use with the present systems can be of any kind,size, or shape known to those skilled in the art; for example,FREESTYLE® and FREESTYLE LITE™ test strips, as well as PRECISION™ teststrips sold by ABBOTT DIABETES CARE Inc. In addition to the embodimentsspecifically disclosed herein, the systems of the present disclosure canbe configured to work with a wide variety of analyte test strips, e.g.,those disclosed in U.S. patent application Ser. No. 11/461,725, filedAug. 1, 2006; U.S. Patent Application Publication No. 2007/0095661; U.S.Patent Application Publication No. 2006/0091006; U.S. Patent ApplicationPublication No. 2006/0025662; U.S. Patent Application Publication No.2008/0267823; U.S. Patent Application Publication No. 2007/0108048; U.S.Patent Application Publication No. 2008/0102441; U.S. Patent ApplicationPublication No. 2008/0066305; U.S. Patent Application Publication No.2007/0199818; U.S. Patent Application Publication No. 2008/0148873; U.S.Patent Application Publication No. 2007/0068807; U.S. patent applicationSer. No. 12/102,374, filed Apr. 14, 2008, and U.S. Patent ApplicationPublication No. 2009/0095625; U.S. Pat. No. 6,616,819; U.S. Pat. No.6,143,164; U.S. Pat. No. 6,592,745; U.S. Pat. No. 6,071,391 and U.S.Pat. No. 6,893,545; the disclosures of each of which are incorporated byreference herein in their entirety.

Integrated with Lancing Device

In another embodiment, an analyte measurement system may include anintegrated analyte test meter and lancing device for providing a bodilyfluid sample, such as a blood sample, and measuring an analyteconcentration, such as a blood glucose concentration. Examples of suchintegrated systems include systems and devices described in US PublishedApplication Nos. US2007/0149897 and US2008/0167578, the disclosures ofeach of which are incorporated herein by reference in their entirety.

Calculation of Medication Dosage

In one embodiment, the analyte measurement system may be configured tomeasure the blood glucose concentration of a patient and includeinstructions for a long-acting insulin dosage calculation function.Periodic injection or administration of long-acting insulin may be usedto maintain a baseline blood glucose concentration in a patient withType-1 or Type-2 diabetes. In one aspect, the long-acting medicationdosage calculation function may include an algorithm or routine based onthe current blood glucose concentration of a diabetic patient, tocompare the current measured blood glucose concentration value to apredetermined threshold or an individually tailored threshold asdetermined by a doctor or other treating professional to determine theappropriate dosage level for maintaining the baseline glucose level. Inone embodiment, the long-acting insulin dosage calculation function maybe based upon LANTUS® insulin, available from Sanofi-Aventis, also knownas insulin glargine. LANTUS® is a long-acting insulin that has up to a24 hour duration of action. Further information on LANTUS® insulin isavailable at the website located by placing “www” immediately in frontof “.lantus.com”. Other types of long-acting insulin include Levemir®insulin available from NovoNordisk (further information is available atthe website located by placing “www” immediately in front of“.levemir-us.com”. Examples of such embodiments are described in USPublished Patent Application No. US2010/01981142, the disclosure ofwhich is incorporated herein by reference in its entirety.

Docking Station

In another embodiment, the analyte measurement system may include acorresponding docking station or one or more other peripheral devices.The docking station may include, among others, a transmitter wherebywhen the analyte measurement system is docked to the docking station,the analyte measurement system and docking station may communicate overa data network with, for example, a healthcare provider, for thetransfer of data or receipt of instructions or new dosage regimens. Thedocking station transmitter may be configured for transmission protocolsincluding, but not limited to, cellular telephone transmission, such ascode division multiple access (CDMA) or Global System for Mobilecommunications (GSM), internet communication, facsimile communications,and/or telephone communication. In another aspect, the docking stationmay also be configured to provide power for recharging a rechargeablebattery of the analyte measurement system. In another aspect, thedocking station may be configured for communication with a personalcomputer for additional storage, programming, and/or communication.

In another embodiment, a docking station such as described in U.S. Pat.No. 7,077,328 may be employed. As stated above, U.S. Pat. No. 7,077,328is incorporated herein by reference in its entirety.

Strip Port Configured to Receive Test Strips for Different Analytes

In another embodiment, there is provided an analyte measurement systemfor multichemistry testing. The test strips are for chemical analysis ofa sample, and are adapted for use in combination with a measuring devicehaving a test port and capable of performing a multiplicity of testingfunctionalities. Each type of test strip corresponds to at least one ofthe testing functionalities, and at least some types of test strips haveindicators of the testing functionality on them. The test port isadapted for use in combination with a multiplicity of different types oftest strips and includes a sensor capable of specifically interactingwith the indicator(s) on the test strips, thereby selecting at least oneof the multiplicity of testing functionalities corresponding to the typeof test strip. Such system would include a strip port that can be usedto read a test strip for glucose and a test strip for ketone bodies.Examples of such embodiment are provided in U.S. Pat. No. 6,773,671,which is incorporated herein by reference in it entirety.

Strip Port Configured to Receive Test Strips Having Different Dimensionsand/or Electrode Configurations

In some embodiments, an analyte measurement system as described hereinincludes a strip port configured to receive test strips having differentdimensions and/or electrode configurations, e.g., as described in theU.S. patent application Ser. No. 12/695,947 filed on Jan. 28, 2010, andentitled “Universal Test Strip Port”, the disclosure of which isincorporated by reference herein in its entirety.

Test Strip Ejector

In some embodiments, an analyte measurement system as described hereinis configured to include an optional analyte test strip ejectorconfigured to eject an analyte test strip from a test strip port of theanalyte measurement system. An analyte test strip ejector may be useful,for example, where it is desirable to eject an analyte test stripcontaining a sample of bodily fluid, e.g., blood, following an analytemeasurement conducted using the analyte measurement system. This allowsa user of the analyte measurement system to dispose of the contaminatedanalyte test strip without touching the analyte test strip.

In some embodiments, the analyte test strip ejector slidably engages aportion of the housing of the analyte measurement system. The analytetest strip ejector may be configured such that upon insertion of ananalyte test strip into the test strip port, the analyte test stripejector is moved rearward with respect to the test strip port and in thedirection of insertion. In order to eject the analyte test strip, a userphysically moves the analyte test strip ejector forward with respect tothe test strip port and in the opposite of the direction of insertion.This movement in-turn exerts force upon the analyte test strip expellingit from the test strip port. Alternatively, the analyte test stripejector may be configured such that insertion of the analyte test stripinto a strip port of the analyte measurement system positions theanalyte test strip ejector in a “cocked” position, e.g., by engaging aspring mechanism. The analyte measurement system may include a button,switch, or other suitable mechanism for releasing the cocked ejectorfrom the cocked position such that it ejects the analyte test strip fromthe strip port of the analyte measurement system. Additional informationregarding analyte test strip ejectors is provided in the U.S. patentapplication Ser. No. 12/695,947, filed on Jan. 28, 2010, and entitled“Universal Test Strip Port.”

Splash-Proof Test Strip Port

In some embodiments, an analyte measurement system as described hereinis configured to include a contamination resistant test strip portand/or a splash-proof test strip port. In one such embodiment, the teststrip port includes one or more sealing members positioned so as tolimit and/or prevent internal contamination of the test strip port withfluids and/or particles present in the environment outside the teststrip port. In another embodiment, the test strip port includes aninternal beveled face which can limit and/or prevent ingress of one ormore external contaminants into the internal area of the test stripport.

Additional disclosure and examples of contamination resistant test stripports are provided in U.S. patent application Ser. No. 12/539,217, filedAug. 11, 2009, and entitled “Analyte Sensor Ports,” the disclosure ofwhich is incorporated by reference herein in its entirety.

In some embodiments, the test strip ports described herein can beconfigured to work with (e.g., engage with or operate in connectionwith) additional mechanisms and/or devices designed to limit and/orprevent contamination of the internal areas of the test strip portsthemselves or the internal areas of the analyte measurement system intowhich the test strip ports can be integrated. For example, mechanisms,devices and methods of protecting test strip port openings are describedin U.S. Patent Application Publication No. US2008/0234559, and U.S.Patent Application Publication No. US2008/0119709, the disclosure ofeach of which is incorporated by reference herein in their entirety.Test strip ports according to the present disclosure can also beconfigured to be replaceable and/or disposable, and/or configured so asto limit and/or prevent contamination of the analyte measurement systemin which the test strip port is integrated. Additional description isprovided, for example, in U.S. Application Publication No. 2010/0064800,the disclosure of which is incorporated by reference herein it itsentirety.

Implanted Analyte Sensor

In some embodiments, an analyte measurement system as described hereinmay include an implanted or partially implanted analyte sensor, e.g., asystem including an implanted or partially implanted glucose sensor(e.g., a continuous glucose sensor). A system including an implanted orpartially implanted glucose sensor may include an analyte measurementsystem as described herein, which is configured to receive analyte datafrom the implanted or partially implanted glucose sensor either directlyor through an intermediate device, e.g., an RF-powered measurementcircuit coupled to an implanted or partially implanted analyte sensor.In some embodiments, where an analyte measurement system according tothe present disclosure is integrated with an implanted sensor, theanalyte measurement system does not include a strip port for receivingan analyte test strip. In one embodiment, the analyte measurement systemmay be used to calibrate the analyte monitoring system, e.g., using onepoint calibration or other calibration protocol. For additionalinformation, see U.S. Pat. No. 6,175,752, the disclosure of which isincorporated by reference herein in its entirety. In some embodiments,the analyte measurement system may be configured to communicate with theimplanted or partially implanted analyte sensor via Radio FrequencyIdentification (RFID) and provide for intermittent or periodicinterrogation of the implanted analyte sensor.

Exemplary analyte monitoring systems that may be utilized in connectionwith the disclosed analyte measurement system include those described inU.S. Pat. No. 7,041,468; U.S. Pat. No. 5,356,786; U.S. Pat. No.6,175,752; U.S. Pat. No. 6,560,471; U.S. Pat. No. 5,262,035; U.S. Pat.No. 6,881,551; U.S. Pat. No. 6,121,009; U.S. Pat. No. 7,167,818; U.S.Pat. No. 6,270,455; U.S. Pat. No. 6,161,095; U.S. Pat. No. 5,918,603;U.S. Pat. No. 6,144,837; U.S. Pat. No. 5,601,435; U.S. Pat. No.5,822,715; U.S. Pat. No. 5,899,855; U.S. Pat. No. 6,071,391; U.S. Pat.No. 6,120,676; U.S. Pat. No. 6,143,164; U.S. Pat. No. 6,299,757; U.S.Pat. No. 6,338,790; U.S. Pat. No. 6,377,894; U.S. Pat. No. 6,600,997;U.S. Pat. No. 6,773,671; U.S. Pat. No. 6,514,460; U.S. Pat. No.6,592,745; U.S. Pat. No. 5,628,890; U.S. Pat. No. 5,820,551; U.S. Pat.No. 6,736,957; U.S. Pat. No. 4,545,382; U.S. Pat. No. 4,711,245; U.S.Pat. No. 5,509,410; U.S. Pat. No. 6,540,891; U.S. Pat. No. 6,730,200;U.S. Pat. No. 6,764,581; U.S. Pat. No. 6,299,757; U.S. Pat. No.6,461,496; U.S. Pat. No. 6,503,381; U.S. Pat. No. 6,591,125; U.S. Pat.No. 6,616,819; U.S. Pat. No. 6,618,934; U.S. Pat. No. 6,676,816; U.S.Pat. No. 6,749,740; U.S. Pat. No. 6,893,545; U.S. Pat. No. 6,942,518;U.S. Pat. No. 6,514,718; U.S. Pat. No. 5,264,014; U.S. Pat. No.5,262,305; U.S. Pat. No. 5,320,715; U.S. Pat. No. 5,593,852; U.S. Pat.No. 6,746,582; U.S. Pat. No. 6,284,478; U.S. Pat. No. 7,299,082; U.S.Patent Application No. 61/149,639, entitled “Compact On-BodyPhysiological Monitoring Device and Methods Thereof”, U.S. patentapplication Ser. No. 11/461,725, filed Aug. 1, 2006, entitled “AnalyteSensors and Methods”; U.S. patent application Ser. No. 12/495,709, filedJun. 30, 2009, entitled “Extruded Electrode Structures and Methods ofUsing Same”; U.S. Patent Application Publication No. US2004/0186365;U.S. Patent Application Publication No. 2007/0095661; U.S. PatentApplication Publication No. 2006/0091006; U.S. Patent ApplicationPublication No. 2006/0025662; U.S. Patent Application Publication No.2008/0267823; U.S. Patent Application Publication No. 2007/0108048; U.S.Patent Application Publication No. 2008/0102441; U.S. Patent ApplicationPublication No. 2008/0066305; U.S. Patent Application Publication No.2007/0199818; U.S. Patent Application Publication No. 2008/0148873; U.S.Patent Application Publication No. 2007/0068807; US patent ApplicationPublication No. 2010/0198034; and U.S. provisional application No.61/149,639 titled “Compact On-Body Physiological Monitoring Device andMethods Thereof”, the disclosures of each of which are incorporatedherein by reference in their entirety.

Integration with Medication Delivery Devices and/or Systems

In some embodiments, the analyte measurement systems disclosed hereinmay be included in and/or integrated with, a medication delivery deviceand/or system, e.g., an insulin pump module, such as an insulin pump orcontroller module thereof. In some embodiments the analyte measurementsystem is physically integrated into a medication delivery device. Inother embodiments, an analyte measurement system as described herein maybe configured to communicate with a medication delivery device oranother component of a medication delivery system. Additionalinformation regarding medication delivery devices and/or systems, suchas, for example, integrated systems, is provided in U.S. PatentApplication Publication No. US2006/0224141, published on Oct. 5, 2006,entitled “Method and System for Providing Integrated Medication Infusionand Analyte Monitoring System”, and U.S. Patent Application PublicationNo. US2004/0254434, published on Dec. 16, 2004, entitled “GlucoseMeasuring Module and Insulin Pump Combination,” the disclosure of eachof which is incorporated by reference herein in its entirety. Medicationdelivery devices which may be provided with analyte measurement systemas described herein include, e.g., a needle, syringe, pump, catheter,inhaler, transdermal patch, or combination thereof. In some embodiments,the medication delivery device or system may be in the form of a drugdelivery injection pen such as a pen-type injection device incorporatedwithin the housing of an analyte measurement system. Additionalinformation is provided in U.S. Pat. Nos. 5,536,249 and 5,925,021, thedisclosures of each of which are incorporated by reference herein intheir entirety.

Communication Interface

As discussed previously herein, an analyte measurement system accordingto the present disclosure can be configured to include a communicationinterface. In some embodiments, the communication interface includes areceiver and/or transmitter for communicating with a network and/oranother device, e.g., a medication delivery device and/or a patientmonitoring device, e.g., a continuous glucose monitoring device. In someembodiments, the communication interface is configured for communicationwith a health management system, such as the CoPilot™ system availablefrom Abbott Diabetes Care Inc., Alameda, Calif.

The communication interface can be configured for wired or wirelesscommunication, including, but not limited to, radio frequency (RF)communication (e.g., Radio-Frequency Identification (RFID), Zigbeecommunication protocols, WiFi, infrared, wireless Universal Serial Bus(USB), Ultra Wide Band (UWB), Bluetooth® communication protocols, andcellular communication, such as code division multiple access (CDMA) orGlobal System for Mobile communications (GSM).

In one embodiment, the communication interface is configured to includeone or more communication ports, e.g., physical ports or interfaces suchas a USB port, an RS-232 port, or any other suitable electricalconnection port to allow data communication between the analytemeasurement system and other external devices such as a computerterminal (for example, at a physician's office or in hospitalenvironment), an external medical device, such as an infusion device orincluding an insulin delivery device, or other devices that areconfigured for similar complementary data communication.

In one embodiment, the communication interface is configured forinfrared communication, Bluetooth® communication, or any other suitablewireless communication protocol to enable the analyte measurement systemto communicate with other devices such as infusion devices, analytemonitoring devices, computer terminals and/or networks, communicationenabled mobile telephones, personal digital assistants, or any othercommunication devices which the patient or user of the analytemeasurement system may use in conjunction therewith, in managing thetreatment of a health condition, such as diabetes.

In one embodiment, the communication interface is configured to providea connection for data transfer utilizing Internet Protocol (IP) througha cell phone network, Short Message Service (SMS), wireless connectionto a personal computer (PC) on a Local Area Network (LAN) which isconnected to the internet, or WiFi connection to the internet at a WiFihotspot.

In one embodiment, the analyte measurement system is configured towirelessly communicate with a server device via the communicationinterface, e.g., using a common standard such as 802.11 or Bluetooth® RFprotocol, or an IrDA infrared protocol. The server device could beanother portable device, such as a smart phone, Personal DigitalAssistant (PDA) or notebook computer; or a larger device such as adesktop computer, appliance, etc. In some embodiments, the server devicehas a display, such as a liquid crystal display (LCD), as well as aninput device, such as buttons, a keyboard, mouse or touch-screen. Withsuch an arrangement, the user can control the analyte measurement systemindirectly by interacting with the user interface(s) of the serverdevice, which in turn interacts with the analyte measurement systemacross a wireless link.

In some embodiments, the communication interface is configured toautomatically or semi-automatically communicate data stored in theanalyte measurement system, e.g., in an optional data storage unit, witha network or server device using one or more of the communicationprotocols and/or mechanisms described above.

Input Unit

As discussed previously herein, an analyte measurement system accordingto the present disclosure can be configured to include an input unitand/or input buttons coupled to the housing of the analyte measurementsystem and in communication with a controller unit and/or processor. Insome embodiments, the input unit includes one or more input buttonsand/or keys, wherein each input button and/or key is designated for aspecific task. Alternatively, or in addition, the input unit may includeone or more input buttons and/or keys that can be ‘soft buttons’ or‘soft keys’. In the case where one or more of the input buttons and/orkeys are ‘soft buttons’ or ‘soft keys’, these buttons and/or keys may beused for a variety of functions. The variety of functions may bedetermined based on the current mode of the analyte measurement system,and may be distinguishable to a user by the use of button instructionsshown on an optional display unit of the analyte measurement system. Yetanother input method may be a touch-sensitive display unit, as describedin greater detail below.

In addition, in some embodiments, the input unit is configured such thata user can operate the input unit to adjust time and/or dateinformation, as well as other features or settings associated with theoperation of an analyte measurement system.

Display Unit

As discussed previously herein, in some embodiments, an analytemeasurement system according to the present disclosure includes anoptional display unit or a port for coupling an optional display unit tothe analyte measurement system. The display unit is in communicationwith a control unit and/or processor and displays the analyte test stripsignals and/or results determined from the analyte test strip signalsincluding, for example, analyte concentration, rate of change of analyteconcentration, and/or the exceeding of a threshold analyte concentration(indicating, for example, hypo- or hyperglycemia).

The display unit can be a dot-matrix display, e.g., a dot-matrix LCDdisplay. In some embodiments, the display unit includes a liquid-crystaldisplay (LCD), thin film transistor liquid crystal display (TFT-LCD),plasma display, light-emitting diode (LED) display, seven-segmentdisplay, E-ink (electronic paper) display or combination of two or moreof the above. The display unit can be configured to provide, analphanumeric display, a graphical display, a video display, an audiodisplay, a vibratory output, or combinations thereof. The display can bea color display. In some embodiments, the display is a backlit display.

The display unit can also be configured to provide, for example,information related to a patient's current analyte concentration as wellas predictive analyte concentrations, such as trending information.

In some embodiments an input unit and a display unit are integrated intoa single unit, for example, the display unit can be configured as atouch sensitive display, e.g., a touch-screen display, where the usermay enter information or commands via the display area using, forexample, the user's finger, a stylus or any other suitable implement,and where, the touch sensitive display is configured as the userinterface in an icon driven environment, for example.

In some embodiments, the display unit does not include a screen designedto display results visually. Instead, in some embodiments the optionaldisplay unit is configured to communicate results audibly to a user ofthe analyte measurement system, e.g., via an integrated speaker, or viaseparate speakers through a headphone jack or Bluetooth® headset.

Expanding Menu Item for Improved Readability

In some embodiments, the display unit includes a graphical userinterface including a plurality of menu items, wherein the display unitis configured to provide clarification with respect to the meaning of amenu item based on a user's response speed with respect to a user inputfor the menu item. The menu item could take any of a variety of forms,e.g., text, icon, object or combination thereof.

In one embodiment, the graphical user interface includes a menu which inturn includes a plurality of selectable menu items. As a user navigatesthrough the menu, e.g., by highlighting or scrolling through individualmenu items, a menu item that is either unreadable or incomprehensible tothe user could cause the user to pause over a menu item to be selected.In one embodiment, a choice can be presented to the user, e.g., using adedicated physical button on an input unit, or a soft key on the menu,that offers further explanation of the item to be selected withoutactually selecting the item. For example, the graphical user interfacecan be configured such that after a pre-determined period of time a softkey offers an explanation of the menu item to be selected, e.g., bydisplaying a soft key with the word “MORE”, “ADDITIONAL INFORMATION”,“EXPAND”, “MAGNIFY”, “HELP” or a variation thereof displayed thereon.

The pre-determined period of time may be based on a fixed factory presetvalue, a value set by the user or a health care provider, or through anadaptive mechanism based on an analysis of the user's speed ofnavigation from past interactions with the graphical user interface. Inone embodiment, the pre-determined period of time is from about 5 toabout 20 seconds, e.g., from about 10 to about 15 seconds.

If the offer for clarification and/or additional information isselected, e.g., by pressing the softkey, then the menu item to beselected can be displayed in a “high emphasis” mode, e.g., where theitem is displayed as if a magnifying lens is held on top of the selecteditem. In some embodiments, additional emphasis of the menu item to beselected can be provided, e.g., by making the menu item change color,blink, or increase in size to a pre-determined maximum limit.

Support for Intermittent Analyte Determination Using an Analyte Sensor

In some embodiments, an analyte measurement system according to thepresent disclosure is further configured to receive analyteconcentration data and/or signals indicative of an analyte concentrationfrom an analyte sensor, e.g., an implanted or partially implantedanalyte sensor or a radio-frequency (RF)-powered measurement circuitcoupled to an implanted or partially implanted analyte sensor. In someembodiments, the analyte sensor is a self-powered analyte sensor. Ananalyte measurement system according to the present disclosure mayinclude software configured to analyze signals received from the analytesensor. Additional information related to self-powered analyte sensorsand methods of communicating therewith are provided in U.S. PatentApplication Publication No. 2010/0213057, the disclosure of which isincorporated by reference herein in its entirety.

Integrated Bar Code

In an embodiment, an analyte measurement system according to the presentdisclosure is integrated with a barcoding system. The barcoding systemmay be laser or LED based, and may be used for identification of analytetest strips, patient, health care professional, etc. For example, theanalyte measurement system may include a barcode reader disposed in thehousing. The housing would further require a internal circuitry and abarcode scan engine for processing of a scan. Additional examples ofsuch a bar coding system is provided in U.S. Pat. No. 7,077,328, whichhas been incorporated herein by reference in its entirety.

Anti-Microbial Thin Film Cover

In an embodiment, an analyte measurement system according to the presentdisclosure is provided with an anti-microbial thin film cover. A commonproblem with many analyte measurement systems is that the housingcracks, degrades, and generally wears down due to the harsh chemicalsthat are used to disinfect the analyte measurement system in hospitaland clinical environments. By placing an anti-microbial plastic filmover the analyte measurement system, the life-cycle of the system can beprolonged because the plastic film is subjected to the disinfectants,rather than the system housing itself. When the plastic film begins todegrade, it can be removed and replaced. The plastic film also adds anadditional layer of sterility to the system. The plastic film may betransparent, and applied over the display and/or user interface. Oneside of the plastic film would contain anti-microbial chemistry, whilethe back side of the plastic film would contain a thin layer ofadhesive.

Analytes

A variety of analytes can be detected and quantified using the disclosedanalyte measurement system. Analytes that may be determined include, forexample, acetyl choline, amylase, bilirubin, cholesterol, chorionicgonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,fructosamine, glucose, glutamine, growth hormones, hormones, ketones(e.g., ketone bodies), lactate, oxygen, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined. Assayssuitable for determining the concentration of DNA and/or RNA aredisclosed in U.S. Pat. No. 6,281,006 and U.S. Pat. No. 6,638,716, thedisclosures of each of which are incorporated by reference herein intheir entirety.

CONCLUSION

The foregoing description of the invention has been presented forpurposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise form disclosed.Other modifications and variations may be possible in light of the aboveteachings. The embodiments were chosen and described in order to bestexplain the principles of the invention and its practical application,and to thereby enable others skilled in the art to best utilize theinvention in various embodiments and various modifications as are suitedto the particular use contemplated. It is intended that the appendedclaims be construed to include other alternative embodiments of theinvention; including equivalent structures, components, methods, andmeans.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

In the description of the invention herein, it will be understood that aword appearing in the singular encompasses its plural counterpart, and aword appearing in the plural encompasses its singular counterpart,unless implicitly or explicitly understood or stated otherwise. Merelyby way of example, reference to “an” or “the” “analyte” encompasses asingle analyte, as well as a combination and/or mixture of two or moredifferent analytes, reference to “a” or “the” “concentration value”encompasses a single concentration value, as well as two or moreconcentration values, and the like, unless implicitly or explicitlyunderstood or stated otherwise. Further, it will be understood that forany given component described herein, any of the possible candidates oralternatives listed for that component, may generally be usedindividually or in combination with one another, unless implicitly orexplicitly understood or stated otherwise. Additionally, it will beunderstood that any list of such candidates or alternatives, is merelyillustrative, not limiting, unless implicitly or explicitly understoodor stated otherwise.

Various terms are described above to facilitate an understanding of theinvention. It will be understood that a corresponding description ofthese various terms applies to corresponding linguistic or grammaticalvariations or forms of these various terms. It will also be understoodthat the invention is not limited to the terminology used herein, or thedescriptions thereof, for the description of particular embodiments.Merely by way of example, the invention is not limited to particularanalytes, bodily or tissue fluids, blood or capillary blood, or sensorconstructs or usages, unless implicitly or explicitly understood orstated otherwise, as such may vary.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the application. Nothing hereinis to be construed as an admission that the embodiments of the inventionare not entitled to antedate such publication by virtue of priorinvention. Further, the dates of publication provided may be differentfrom the actual publication dates which may need to be independentlyconfirmed.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or more,but not all exemplary embodiments of the present invention ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention and the appended claims in any way.

What is claimed is:
 1. A method of determining a concentration of ananalyte, comprising: depositing a sample of biological fluid on ananalyte test strip positioned in a strip port of an analyte meter,comprising a meter housing; a display; a removable strip port modulehaving an output interface positioned wholly within the meter housing ofthe analyte meter and in electrical communication with an inputinterface of the analyte meter, an analyte test strip port disposedexternal to the meter housing of the analyte meter, and a connectorlinking the output interface at a distal end and the analyte test stripport at a proximal end, wherein the analyte meter lacks an integratedanalyte test strip port in the meter housing; determining aconcentration of the analyte in the biological sample using the analytemeter; and displaying the determined concentration of analyte on thedisplay of the analyte meter.
 2. The method of claim 1, wherein theanalyte test strip is a glucose test strip.
 3. The method of claim 1,wherein the analyte test strip is a ketone test strip.
 4. The method ofclaim 1, wherein the connector is a retractable cord.
 5. The method ofclaim 1, wherein the analyte meter comprises a health managementcommunication interface.
 6. The method of claim 5, wherein the healthmanagement communication interface is a wired interface.
 7. The methodof claim 5, wherein the health management communication interface is awireless interface.
 8. The method of claim 7, wherein the healthmanagement communication interface is a wireless interface configuredfor communication via radio frequency communication, Zigbeecommunication protocols, WiFi, infrared, wireless Universal Serial Bus,Ultra Wide Band, Bluetooth® communication protocols, or cellularcommunication protocols.
 9. The method of claim 1, wherein the systemcomprises a docking station for the analyte meter.
 10. The method ofclaim 9, wherein the docking station comprises a transmitter thattransmits data over a data network.
 11. The method of claim 9, whereinthe docking station comprises a battery charger.
 12. The method of claim1, wherein the analyte meter comprises a user interface.
 13. The methodof claim 12, wherein the user interface is a touchscreen monitor. 14.The method of claim 1, wherein the analyte test strip port comprises atest strip ejector.
 15. The method of claim 1, wherein the analyte teststrip port comprises a sealing member.
 16. The method of claim 1,wherein the analyte test strip port comprises an internal beveled face.17. The method of claim 1, wherein the bodily biological fluid is blood.18. The method of claim 1, wherein prior to the step of depositing,lancing skin of a subject to provide the bodily biological fluid. 19.The method of claim 18, wherein the subject is a neonatal subject. 20.The method of claim 1, wherein the analyte test strip port is positionedinside an incubator and the meter housing is positioned outside theincubator.